Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaProTM Cream Base
2011
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Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaProTM Cream Base
Published Date
2011
Publisher
University of Minnesota, College of Pharmacy
Type
Article
Abstract
The United States Pharmacopeia-National Formulary (USP-NF) suggests beyond use dating ((BUD) for compounded topical
preparations containing active pharmaceutical ingredients (API) [1]. The beyond the use dates of the preparations are based on the
conservative and empirical guidelines of USP 795. Hydrocortisone (HC) content compounded in the VersaPro™ base cream was
quantified using a HPLC method at time zero and after 30 and 60 days of storage at both room temperature and 4℃. The analysis
suggests that the compounded preparations retain > 95% of the stated initial potency of HC regardless of storage conditions. Thus
HC creams prepared in VersaPro™ cream base can be safely assigned a beyond the use date of two months when stored at room
temperature.
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Previously Published Citation
Sarkar AB, Dudley R, Melethil S, Speidel J, Bhatt GM. Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaProTM Cream Base. 2011; 3(54):1-3.
Suggested citation
Sarkar, Arindam Basu; Dudley, Richard; Melethil, Srikumaran; Speidel, Jonathon; Bhatt, Gopalkumar Markandakumar. (2011). Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaProTM Cream Base. Retrieved from the University Digital Conservancy, https://hdl.handle.net/11299/116891.
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